Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach (ANOTES)

Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach: Randomized, Double-blind Study

The research procedure is the injection of 20 mL of Ropivacaine solution (vs. saline) to create a paracervical block at the beginning of surgery, while the patient is already under general anesthesia.

This injection will take place 3 minutes before the vaginal incision, via 4 injection points. Injections are made 3 mm deep into the vaginal cul de sac.

Randomization takes place before surgery by vNOTES:

• Experienced group: Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg) and general anesthesia
• Control group: Injection of 20mL of placebo (saline) and general anesthesia

In both groups, systematic intraoperative and postoperative analgesia will be identical.

Study Overview

• Status: Recruiting
• Conditions: Hysterotomy; Affecting Fetus
• Intervention / Treatment: Drug: Naropeine; Other: questionnaires; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Patrice Crochet, Dr; Phone Number: +33 06 88 38 48 03; Email: Patrice.Crochet@chu-rouen.fr

Study Locations

• France
  • Le Havre, France, 76083
    • Recruiting
    • GH Le Havre
    • Contact: Anthony Feraille, Dr; Phone Number: 02 32 73 32 32; Email: Anthony.feraille@ch-havre.fr
    • Principal Investigator: Anthony Feraille, Dr
  • Rouen, France, 76031
    • Recruiting
    • CHU Rouen
    • Sub-Investigator: Patrice Crochet, Dr
    • Contact: Patrice Crochet, Dr; Phone Number: +33 06 88 38 48 03; Email: Patrice.Crochet@chu-rouen.fr
    • Principal Investigator: Morgane Perrin, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged 18 to 70 inclusive
• Patient scheduled for vNOTES surgery for total hysterectomy for benign pathology, whether or not associated with an adnexal procedure (unilateral or bilateral salpingectomy or adnexectomy (for cysts smaller than 6 cm)).
• Person having read and understood the information letter and signed the consent form
• Person affiliated to a social security scheme

Exclusion Criteria:

• Suspicion of malignant pathology
• History of rectal surgery
• History of pelvic inflammatory disease
• Suspicion of recto-vaginal endometriosis
• Virginity
• Contraindication to NAROPEINE 7.5 mg/mL, solution for injection in ampoule
• Contraindication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection
• Patients on a low-salt diet
• History of more than 2 caesarean sections
• Estimated uterine size > 700 g according to the following formula y = 0.35x + 107 (x = a × b × c), based on measurements taken on preoperative imaging (MRI or ultrasound). a=longitudinal diameter, b=sagital diameter, c=transverse diameter.3
• BMI > 35
• Contraindication to analgesic molecules in intraoperative and postoperative protocols.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experienced group; Administration of Naropeine	Drug: Naropeine; Local anesthesia with injection of Ropivacaine (20mL of ropivacaine 7.5 mg/mL, i.e. 150mg); Other: questionnaires; Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4
Placebo Comparator: Control group; Administration of a saline solution	Other: questionnaires; Numerical Rating scale Questionnaire FSFI Qustionnaire SF12 Questionnaire DN4; Other: Placebo; Injection of 20 mL of NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain after surgery	Pain will be assessed by the post-operative hospital nurse using a numerical rating scale (NRS) NRS score from 1 to 10 -> 10 correspoding to the worst pain	4hours after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Collaborators: Groupe Hospitalier du Havre

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Organic Chemicals; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine; Surveys and Questionnaires
• Other Study ID Numbers: 2022/0270/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No